Kornimate/medical-research-clean huggingface dataset:
phase ib/ii study of shr-8068 injection in the treatment of advanced non-small cell lung cancer

Conditions: Advanced Non-small Cell Lung Cancer

Summary: to evaluate the tolerability and safety of shr-8068 in combination with adebrelimab in subjects with advanced nsclc to evaluate the efficacy of shr-8068 in combination with adebrelimab and platinum-based chemotherapy in subjects with advanced nsclc


Eligibility criteria:
inclusion criteria: 1. age 18\~75 years old, both male and female 2. stage 1: pathologically diagnosed, incurable nsclc subjects who have failed standard treatment 3. stage 2: have a histologically or cytologically confirmed diagnosis of relapsed or metastatic nsclc; have not received prior systemic treatment for their recurrent or metastatic nsclc; pd-l1 tps \<50% as confirmed by central laboratory 4. at least one measurable lesion based on recist v1.1 criteria 5. ecog ps score: 0-1 points 6. expected survival period ≥ 3 months 7. good levels of organ function 8. patients voluntarily joined the study and signed informed consent exclusion criteria: 1. patients with egfr activating mutation, positive alk fusion gene or known ros1 fusion gene 2. untreated brain metastases; or associated with meningeal metastases, spinal cord compression, etc. 3. uncontrolled pleural, pericardial, or ascites with clinical symptoms 4. severe bone damage caused by tumor bone metastasis 5. suffering from other malignant tumors in the past 3 years or at the same time 6. presence of any active or known autoimmune disease 7. systemic treatment with corticosteroids or other immunosuppressants within 2 weeks before the first dose 8. have clinical symptoms or diseases of the heart that are not well controlled 9. serious infection occurred within 1 month before the first dose 10. past or current active interstitial lung disease requiring treatment, non-infectious pneumonia requiring glucocorticoid system treatment; current active pneumonia or pulmonary function test confirmed severe impairment of pulmonary function 11. with active pulmonary tuberculosis 12. known positive history of human immunodeficiency virus test or acquired immunodeficiency syndrome, known active viral hepatitis 13. known history of inflammatory bowel disease 14. inoculated with live attenuated vaccine within 28 days before the first dose 15. known allergic reaction to other monoclonal antibodies 16. received \>30 gy of pulmonary radiotherapy within 6 months before the first dose; received major surgical treatment, systemic chemotherapy, immunotherapy or other clinical trial drugs within 4 weeks before the first dose; within 2 weeks before the first dose received palliative radiotherapy; oral molecularly targeted drugs, discontinued to less than 5 half-lives before first dose; failure to recover from toxicity and/or complications of previous interventions to nci-ctc ae ≤1 degree 17. according to the judgment of the researcher, there are other factors that may affect the results of the study or cause the study to be terminated halfway.
observational retrospective study of evaluation of prognostic factors in advanced pancreatic cancer patients treated with folfirinox

Conditions: Pancreatic Cancer Non-resectable

Summary: the aim of this study is to identify new prognostic factors in patients affected by advanced pancreatic carcinoma treated with first line chemotherapy with folfirinox regimen. primary objective is the identification of clinical, laboratory and pathologic factors affecting overall survival of these patients.


Eligibility criteria:
inclusion criteria: * age \>18 years * citologically or histologically confirmed pancreatic carcinoma * disease stage iii or iv according to the american joint committee on cancer (ajcc) staging system * access to clinical informations collected before first-line starting * availability of objective response evaluation and survival data * written informed consent exclusion criteria: * diagnosis of other neoplasia than pancreatic carcinoma * treatment with drugs other than folfirinox * treatment with experimental drugs in combination with folfirinox * unavailability of clinical and pathological data

Keywords: pancreatic cancer chemotherapy folfirinox prognostic
the efficacy of acupuncture as a complementary treatment for pain and anxiety after breast cancer surgery

Conditions: Acupuncture Therapy; Breast Neoplasms

Summary: background: breast cancer is one of the most prevalent cancers worldwide. fortunately, survival has improved in recent years thanks to its early detection and curative treatments such as mastectomy. however, this medical procedure is associated with a range of unwanted effects such as postoperative pain and anxiety. some studies have reported that acupuncture could be an effective treatment to control these types of symptoms, although only few studies have been conducted on women undergoing mastectomy. methods: this is a pragmatic randomized controlled trial with blind assessors. the study will be conducted in the breast unit of hospital universitario sagrado corazon of barcelona (spain). a sample of 40 women will be recruited and randomized to receive acupuncture treatment in addition to standard care procedures, or standard care procedures alone. the main outcome, pain, will be assessed after the surgical intervention and 4, 10 and 30 days later using the numerical rating scale. secondary outcomes include anxiety, use of analgesics, nausea, adverse effects, and surgical complications. discussion: acupuncture is a low-cost non-pharmacological strategy. this study will help to clarify its possible role in controlling post-mastectomy adverse effects.


Eligibility criteria:
inclusion criteria: * diagnosis of breast cancer * primary breast cancer patient * candidate for breast cancer surgery (mastectomy) * aged between 20 and 70 years old * consenting to participate in the study and signing the informed consent form. exclusion criteria: * have a previous history of breast cancer * have a previous diagnosis of a severe psychiatric disorder * present risk factors associated with breast cancer * do not speak spanish or catalan * are currently participating in another trial.
virtual reality with mirror therapy on upper limb function

Conditions: Hemiplegic Cerebral Palsy

Summary: the goal of this clinical trial is to address the effect of (virtual reality) and (mirror therapy) together on upper limb function in hemiplegic cerebral palsy children , male or female ranged between 3 to 10 years of age . the main question of the study is are there any significant differences between the effects of virtual reality , mirror therapy and the combined effect of both techniques and on upper limb function in hemiplegic cp children? participants will be subdevided into three groups a , b ,c group (a): will receive vr in addition to designed physical therapy program group (b): will receive mt in addition to designed physical therapy program group (c): will receive the compound effect of both techniques in addition to designed physical therapy program

the goal of this clinical trial is to address the effect of (virtual reality) and (mirror therapy) together on upper limb function in hemiplegic cerebral palsy children , male or female ranged between 3 to 10 years of age . the main question of the study is are there any significant differences between the effects of virtual reality (vr), mirror therapy (mr) and the combined effect of both techniques (vr) and (mr) on upper limb function in hemiplegic cp children? participants will be subdevided into three groups a , b ,c group (a): will receive vr in addition to designed physical therapy program group (b): will receive mt in addition to designed physical therapy program group (c): will receive the compound effect of both techniques in addition to designed physical therapy program

Eligibility criteria:
inclusion criteria: * children will be included in the study if they fulfil the following criteria: 1. a medical diagnosis of spastic hemiplegic cp made by pediatric neurologists. 2. children with spasticity grades ranged from 1 to 1+ according to mas. 3. their age range from 4 to 10 years. 4. children level 1 and level 2 in gross motor functional classification (gmfc 1\&2) exclusion criteria: * children will be excluded from the study if: 1. they had a permanent deformity (bony or soft tissue contractures). 2. children having visual or auditory defects. 3. children who can not understand verbal commands 4. children who had botox application to the upper extremity in the past 6 months or had undergone a previous surgical intervention to wrist and hand.

Keywords: hemiplagia upper limb function virtual reality mirror therapy xbox 360
the diabetes specialist nurse as delegated main care provider for patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: to determine whether the management of type 2 diabetes mellitus (dm2) can be transferred from an internist to a supervised nurse specialized in diabetes (nsd) with a comparable quality of clinical care, health care costs, health related quality of life (hrqol), and patient satisfaction.

diabetes mellitus type 2 (dm2) is a chronic, progressive illness which causes considerable morbidity and premature mortality.1-2 the worldwide prevalence of dm2 is high and is increasing steadily, also in the netherlands.3-4 the burden of dm2 on health care has also increased because of the intensified cardiovascular risk management being practiced to prevent macrovascular morbidity and mortality in these patients.5 in the treatment of dm2, tight guidelines are increasingly recommended for optimizing glycaemia, blood pressure and lipid profile.6 therefore, the burden of treatment has increased and will further increase per patient as well as per population with dm2. in order to meet this problem, we tested, in the current study, the hypothesis that well defined routine aspects in diabetes care, previously handled only by medical doctors in secondary care setting, may be safely transferred to supervised nurses specialized in diabetes (nsd), including the prescription of medication, resulting in at least the same quality of clinical care, health care costs, health related quality of life (hrqol), and patient satisfaction.

Eligibility criteria:
inclusion criteria: * patients with dm2 who were referred by gps to the diabetes outpatient clinics exclusion criteria: * macroalbuminuria * serum creatinine level \> 135 mol/l, * cockcroft \< 50 ml/min * alanine aminotransferase (alt) \> 120 u/l * pregnant woman

Keywords: randomized controlled trial delegation, professional nurses
the alouette test in parkinson disease

Conditions: Parkinson Disease

Summary: reading disorders in parkinson's disease (pd) are poorly evaluated due to the lack of validated tests to screen for them. they are often attributed to hand tremors associated with the disease. in this study, the investigating team evaluated the "alouette test" validated for dyslexia screening, in pd by comparing the results to healthy patients.


Eligibility criteria:
inclusion criteria: * patients with parkinson's disease * montreal cognitive assessment (moca) test \> 20 exclusion criteria: * patient's with supranuclear palsy * other neurologic disease * any ophthalmologic disease * presence of a nystagmus * visual acuity \< 0.6
the surveillance clinical study of rickettsiosis

Conditions: Rickettsiosis

Summary: the purpose of this surveillance (non-interventional) clinical study is to genotype the causative agents of rickettsiosis in biological samples of patients from the altai republic, russian federation. this is a solely observational study in the patients with diagnosed or suspected tick-borne rickettsioses, with no intervention to the routine treatment and diagnostic process. during the study the medical history, diseases progress and symptoms, as well as treatments are being registered in individual case report forms. the rests of the samples used for standard diagnostics (plasma, or serum, and/or swabs of the tick bite site) are being collected and afterwards will be analyzed for a new rickettsia type. these data will be compared to the medical history and symptoms of the patients in order to identify clinical pattern specific for the new rickettsia type. informed consents from all patients or their legal representatives are being collecting. the study was approved by the local ethical committee.


Eligibility criteria:
inclusion criteria: * written patient's informed concent for study participation; * male and female patients of any age with diagnosed or suspected tick-born rickettsioses. exclusion criteria: - unwillingness to participate in the study by any reason.
detection of either the eml4-alk gene rearrangements or the t790m egfr mutation in the plasma of advanced nsclc patients

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: demonstrate feasibility of detection of eml4-alk fusion transcripts and t790m egfr mutation from exosomes in the circulation of non-small cell lung cancer (nscls) patients.

the goal of this study is two-fold: 1) demonstrate feasibility of detection of eml4-alk fusion transcripts in the circulation of nsclc patients positive for alk on tissue analysis, using an institutionally accepted assay; 2) demonstrate feasibility of detection of t790m egfr mutation in the circulation of nsclc patients positive for t790m on tissue analysis, using an institutionally accepted assay.

Eligibility criteria:
inclusion criteria: 1. participants must have histologically confirmed nsclc, stage iiib- iv, and have tested positive for the presence of eml4-alk on tissue specimen, fresh or archived, using an institutionally accepted assay. 2. age of 18 years or older. 3. participants are being considered for alk-directed therapy or have progressed on egfr tki treatment. 4. participants must have hemoglobin \> 10 mg/dl. 5. ability to understand and willingness to sign a written informed consent document. exclusion criteria: 1. hepatitis (all types) in patient's medical record 2. hiv documented in patient's medical record 3. hemoglobin \< 10 mg/dl 4. less than 18 years of age 5. histologically confirmed nsclc stage i-iiia 6. tested negative for the presence of eml4-alk and t790m egfr on tissue
study of the follow-up of stroke treated with anticoagulants

Conditions: Stroke

Summary: stroke is a major public health problem as it is very frequent (140,000 cases/year in france), and very serious (leading cause of death, 2nd leading cause of dementia, 3rd leading cause of handicap). ischemic cardio-embolic stroke accounts for around 25% of ischemic strokes, and ischemic cardio-embolic stroke in a context of cardiac arrhythmia due to atrial fibrillation (caaf) is the leading non-atheromatous cause. the aim of this study is to optimise the secondary prevention of caaf-related stroke identified at the university hospital of dijon burgundy in the framework of the recommendations of the '2010-2014 stroke plan' and the compulsory consultation at the 6th month (directive dgos//2015/262 of the 3rd august 2015)


Eligibility criteria:
inclusion criteria: * patients managed for stroke at the stroke unit of dijon university hospital for caaf-related cardio-embolic stroke exclusion criteria: * na
vestibulopathy with vestibulo ocular reflex (vor) gain deficit

Conditions: Vestibulopathy, Acute Peripheral

Summary: the study is examine the eye movements characteristics of patients with vor gain deficits (overt and covert saccades) before and after physical therapy intervention program and examine the most effective physical therapy treatment program for patients with vestibulopathy.

the vestibular system receives and conveys information about head motion in space, and is the main human sensory system dedicated to detecting self-motion.the vestibular system plays a crucial role in static and dynamic balance control, stabilizing the head and trunk, especially on unstable surfaces . in terms of postural control and falls, the literature describes a direct association between vor deficits, gait instability, and falls.the "gain" of the vor is defined as the change in the eye angle divided by the change in the head angle during the head turn. under ideal conditions, the gain of the rotational vor is 1.0, meaning there is a compensatory eye velocity equal to the head velocity and in the opposite direction. in case of a positive vhit, the vor gain is decreased and refixating saccades are observed. the video head impulse test measures eye velocity during head rotation. instant feedback about every single head impulse allows the examiner to apply a set of standardized graded impulses. the system is easy to use in a clinical setting, provides an objective measure of the vor, and detects both overt and covert catch-up saccades in patients with vestibular loss. measurements are quick and noninvasive, and the automated analysis software provides instant results.

Eligibility criteria:
inclusion criteria: * diagnosed with unilateral or bilateral vestibulopathy living independently in the community exclusion criteria: * cognitive state decline neurological disorder disease or disorders that can affect balance

Keywords: dizziness instability
brain bold fmri in hypertensive and normotensive participants

Conditions: Hypertension,Essential

Summary: this study will explore the brainstem activity in response to stress in hypertensive patients and normotensive subjects. in addition, it will evaluate if the response in hypertensive patients can be modulated by blocking the afferent signalling of sympathetic nervous system from the kidney to the brain achieved by renal denervation. the investigators hypothesize that the change in bold signal intensity in response to stress is higher in hypertensive patients than in normotensive subjects and that in patients responsive to renal denervation the change in bold signal intensity in response to stress is decreased compared to non-responders or to non-denervated resistant hypertensive patients.

in hypertension, the overactivity of the sympathetic nervous system (sns) has been found to be implicated in its initiation, maintenance and adverse consequences. the sns is composed of an afferent and efferent arm, which brings sensory information to the brain (e.g. brainstem and hypothalamus) and transmits sympathetic outflow from the brain to the peripheral organs, respectively. selective removal of the afferent renal component of the sns can modulate central sympathetic outflow to the kidney, heart and vasculature in animals. the specific contribution of afferent nerve signalling in hypertension and in the potential antihypertensive effect of renal denervation has not been studied in humans.

Eligibility criteria:
inclusion criteria: * signed informed consent * capable of discernment exclusion criteria: * having contra-indications for mri (claustrophobia, cardiac pacemaker or other metallic or mechanical implant or device, etc.) * pregnant women * lower limb sensitive neuropathy * blood pressure \>180/110 mmhg during washout period (for hypertensive patients) * intolerance to sonovue®(ultrasound contrast agent) * acute or chronic disease other than hypertension that influences renal function * taking medication/drugs, except of calcium channel blockers for resistant hypertensive patients

Keywords: sympathetic nervous system blood oxygen level dependent brainstem contrast enhanced ultrasound kidney function hypertension renal denervation
pilot study of the efficacy and safety of lidoderm patch in the treatment of low back pain

Conditions: Chronic Low Back Pain

Summary: patients with moderate to severe chronic low back pain (lbp) despite current analgesic treatment participated in a phase iv clinical trial to evaluate the analgesic efficacy of the lidocaine patch 5% compared to placebo in treating moderate to severe chronic lbp.


Eligibility criteria:
inclusion criteria: 1. were currently experiencing moderate/severe pain despite current analgesic treatment 2. had daily moderate-to-severe lbp for at least 3 months duration 3. had a mean daily pain intensity score of \>6 on a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as the patients have ever imagined (question 5 of bpi) during the baseline week; patients had to complete daily diary assessments at least 5 of 7 days during the baseline week exclusion criteria: 1. had a history of greater than one back surgery, or one back surgery within 3 months of study entry 2. had severe spinal stenosis 3. had chronic back pain of \>12 months duration with an undefined spinal diagnosis 4. had radicular symptoms with radiation into the thigh or below (i.e., knee, calf, foot, etc.) 5. had received an epidural steroid/local anesthetic injection within 2 weeks prior to study entry 6. had received trigger point injections within 2 weeks prior to study entry 7. had received botulinum toxin injections for lbp within 3 months prior to study entry 8. were taking a lidocaine-containing product that could not be discontinued while receiving study medication 9. were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide) 10. had received lidoderm for lbp in the past
type 2 diabetes and alteration of immune system of intestinal mucosa : proof of concept

Conditions: Type 2 Diabetes

Summary: type 2 diabetes is the predominant type of diabetes. because a quiet evolution, it is difficult to have a rapid diagnose. a better knowledge about pathophysiological mechanisms at the origin of type 2 diabetes and about its complications could make it possible to improve the prevention and the treatment of this disease. research team developped a new research axis : the microbiota of the intestinal mucosa. they proved a translocation process of intestinal bacteria from the intestinal mucosa to different tissue of the organism implicated in glucose homeostasis. this mechanism is involved in the type 2 diabetes development. a clinical study (micimab) of predictive biomarkers of diabetes and obesity is ongoing. in parallel, the same team explored the role of intestinal immunity modifications in the bacteria translocation from the gut to the blood circulation. they already have some results on animal model but not yet in human. in animal model, a solid reduction of lymphocytes t cd4 th17 in the intestinal wall is responsable of the translocation of intestinal bacteria and in the induction of a metabolic inflammation wich promotes insulin resistance, abdominal obesity development and type 2 diabetes. the aim of this study is to explore this hypothesis in human to have therapeutic solution later.


Eligibility criteria:
inclusion criteria: * coloscopy indication * capacity to give a written informed consent exclusion criteria: * type 1 diabetes * severe renal failure * antecedent of liver fibrosis and/or liver failure * antecedent of inflammatory bowel disease, lymphocyte colitis, celiac disease or colon cancer * antecedent of obesity surgery or of total colectomy * antecedent of documented intestinal ischaemia * acute infection the week before the inclusion * congenital of acquired immune deficiency * chronic viral infection * antibiotic of probiotic the month before the coloscopy * pregnancy * patients participating to another research with an exclusion period * patients under guardianship

Keywords: coloscopy